E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Exocrine pancreatic insufficiency resulting from chronic pancreatitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033628 |
E.1.2 | Term | Pancreatic insufficiency |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To document MS1819 safety profile in EPI patients due to chronic pancreatitis |
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E.2.2 | Secondary objectives of the trial |
To show preliminary data on MS1819 efficacy in improving dietary fats malabsorption in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female subjects ≥ 18 years of age • Adequate diagnosis of Chronic Pancreatitis • Evidence of Exocrine Pancreatic Insufficiency as confirmed by fecal elastase levels < 100 µg/g stool • History of steatorrhea ≥ 7g/24h (without pancreatic enzymes replacement) • Patients must be naïve of pancreatic enzymes or on optimal dose of enzymes prior to entry in the study • Clinically stable with no evidence of an acute medical condition as evidenced by : medical and medication history, baseline physical examination including vital signs and laboratory analysis • Patients with chronic pancreatitis due to alcohol abuse can be enrolled provided that they show no clinical symptoms of recent alcohol consumption and no alcohol withdrawal symptoms • Females of childbearing potential must use an effective method of contraception (double method contraception) during the study • Females of childbearing potential must have a negative urine pregnancy test at screening • Provide written informed consent
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E.4 | Principal exclusion criteria |
• History of fibrosing colonopathy, decompensated cirrhosis, portal hypertension, liver transplant or lung transplant • Significant bowel resection • Acute pancreatitis or recent exacerbation of chronic pancreatitis • Hepatic enzymes (AST, ALT ,Ph Alkalines) > 3 times the upper limit of normal range • Active or recurrent malignant pancreatic tumor • Patient unable to discontinue the use of pancreatic enzymes • Patients who use bowel stimulant and/or laxatives on a regular basis • Participation in an investigational drug study, biologic, or device not currently approved for marketing within 30 days prior to the Screening Visit • Any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject • Female who are pregnant or breastfeeding
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety assessment: Clinical and biological adverse events, MS1819 plasma detection and anti MS1819 antibodies determination.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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See Section 4.5 of the Protocol |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 15 |